NeuViz Prime Multi-slice CT Scanner System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171201 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NeuViz Prime Multi-slice CT Scanner System is a computed tomography (CT) imaging device designed for high-resolution cross-sectional imaging of the body. It employs multi-slice technology to acquire detailed volumetric data, enabling precise visualization of anatomical structures for diagnostic purposes in radiology.
This system is supplied as a reusable medical device, intended for use in clinical radiology settings. It is regulated under the FDA’s 510(k) pathway with a Traditional review classification, and authorized under the Medical Device Directive (MDD). The device is manufactured by Neusoft Medical Systems Co., Ltd., and its specifications align with the Radiology advisory committee’s product-code category JAK.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CT Scanner Manufacturer，Neusoft CT Scanner, Neusoft CT Scan，CT ..., NeuViz Prime Multi-slice CT Scanner System, NeuViz Prime Max+ CT - neusoftmedical.com, Neusoft - National Imaging Solutions
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K171201 | Class II | Active |
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Manufacturer
- Manufacturer
- Neusoft Medical Systems Co., Ltd.
Sources (2)
- FDA 510(k) K171201 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026